The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery

Inclusion Criteria:

• Symptomatic peripheral vascular occlusive disease (Rutherford-Becker ClinicalCategory 2-4)

• Patient with life expectancy >36 months

• Females of childbearing potential must have negative pregnancy test

• Patient is able to provide informed consent

• Patient agrees to undergo all protocol-required follow-up examinations andrequirements at the investigational site.

• Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed

• Single de novo native disease segment of the superficial femoral artery (SFA) or P1popliteal segment

• Reference vessel diameter ≥5.5 mm and ≤6.5 mm

• Target lesion length ≤90 mm

• Target lesion with ≥50% DS

• Inflow artery and popliteal artery free from flow-limiting lesion (DS <50%)

Exclusion Criteria:

• Hemoglobin <9.0 g/dL

• WBC <3,000 cells/mm3

• Platelet count <80,000 cells/mm3 or >700,000 cells/mm3

• Acute or chronic renal dysfunction with creatinine >2.5 mg/dl (176 µmol/L)

• Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increaseover the normal level of SGOT or SGPT

• A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin,ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannotbe adequately pre-medicated

• Patient requires a planned procedure that would necessitate discontinuation ofantiplatelet therapy

• Patient is unable to walk

• Patient has undergone a percutaneous vascular intervention <30 days prior to theplanned index procedure

• Patient is maintained on chronic hemodialysis

• Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).

• Patient has had a myocardial infarction within the previous 30 days of the plannedindex procedure

• Patient has had a stroke within the previous 30 days of the planned index procedureand/or has deficits from a prior stroke that limits the patient's ability to walk

• Patient has unstable angina defined as rest angina with ECG changes

• Patient has a local groin or acute systemic infection that has not been treatedsuccessfully or is currently under treatment

• Patient has acute thrombophlebitis, deep vein thrombosis or chronic venousinsufficiency in either extremity

• Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.)that may cause the patient to be non-compliant with protocol requirements, confoundthe data interpretation or will prevent completion of all required follow upassessments through 36 months

• Patient is currently participating in an investigational drug, biologic, or devicestudy that has not completed the primary endpoint or that clinically interferes withthe current study endpoints

• Patient has ischemic or neuropathic ulcers on either foot

• Patient has undergone minor or major amputation of either lower extremity

• Patient is part of a vulnerable population who, in the judgment of the Investigator,is unable to give informed consent

• Target extremity with an angiographically significant (>50% DS) lesion locateddistal to the target lesion that requires treatment at the time of the indexprocedure or by a staged procedure

• Acute arterial ischemia of the target extremity

• Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)

• Target vessel has been previously treated with stent, laser, atherectomy, surgicalbypass, or endarterectomy

• Total occlusion (100% DS) of the ipsilateral inflow artery

• Angiographic evidence of thrombus in the target vessel

• The target lesion requires treatment with a device other than percutaneoustransluminal balloon angioplasty (PTA) [e.g., orbital atherectomy, directionalatherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.]

• Target lesion is within or adjacent to an aneurysm

• Patient has angiographic evidence of thromboembolism or atheroembolism fromtreatment of an ipsilateral iliac lesion or from crossing or pre-dilating the targetlesion

• Target lesion has moderate-to-severe calcification

• Target lesion with > 30% residual stenosis following pre-dilatation